Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer (HER-ception)
Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer: Fatigue and Quality of Life During and Waning of Treatment, Psychosocial Aspects (Environment, Work)
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment (spouse, children) during this difficult time for women. Curiously, no study to date has been submitted or published about how women with a one-year treatment "extra" Herceptin ® live this period in terms of quality of life, in terms of psychological impact for themselves and their families.
The investigators have no more data on how often they return to work during this treatment or on the psycho-social parameters which underpin them. It therefore seemed interesting to "give a spotlight" on this particular period in these women HER2 + by comparing a patient population of same age receiving the same adjuvant but with no Herceptin ®.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Calvados
-
Caen, Calvados, France, 14076
- Centre François Baclesse
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Women aged over 18
- Invasive breast carcinoma confirmed histologically
- Non-metastatic cancer
- Surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
- Patient should receive their last course of adjuvant chemotherapy (3 FEC and 3 Taxotere)
- Patients not receiving the third course of Taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of Taxotere
- For the group Herceptin ®: HER2 overexpression without contraindication to treatment administration
- For the control group: no indication for Herceptin ®
- Radiation therapy and / or adjuvant hormonal therapy allowed
- Free and informed consent signed
Exclusion Criteria:
- Women under 18 or over 60 years
- Histology other than adenocarcinoma
- Metastatic Breast Cancer
- Chemotherapy neoadjuvant
- Surgery of the primary tumor unrealized
- Lack of adjuvant chemotherapy with Taxotere 3 FEC and 3
- Patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
- Patient under guardianship or unable to give informed consent,
- Pregnant or lactating
- Patient unable to undergo a medical for geographical, social or psychopathological
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patients group with Herceptin
Patients beginning Herceptin in adjuvant after chemotherapy
|
delivery of questionnaires and self-psychological interview
|
|
Active Comparator: Control group
patient not beginning Herceptin after chemotherapy : control group
|
delivery of questionnaires and self-psychological interview
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
score of fatigue
Time Frame: at 9 months
|
The main objective of this study is to evaluate the score of fatigue in patients with HER2 overexpressing breast cancer and for whom Herceptin ® treatment is prescribed, compared with a population of patients treated with the same age the same chemotherapy without Herceptin ®.
|
at 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess the quality of life
Time Frame: 3, 6, 9 and 12 months
|
Assess the quality of life of patients treated for breast cancer with surgery followed by adjuvant chemotherapy (+/-hormonotherapy) associated with treatment with Herceptin ®, compared with patients of similar age treated with the same chemotherapy without Herceptin ®
|
3, 6, 9 and 12 months
|
|
Impact of Herceptin ® in the professional lives
Time Frame: at 3, 6 ,9 and 12 months
|
Assess the impact of Herceptin ® in the professional lives of patients, compared to patients not treated with Herceptin ®. Evaluation done by a specific questionnaire on professional lives, a scoring will be determined. |
at 3, 6 ,9 and 12 months
|
|
quantitative and qualitative psychological impact of Herceptin ®
Time Frame: at 3 months
|
Assess the quantitative and qualitative psychological impact of Herceptin ® in patients so treated, compared to patients not treated with Herceptin ®. Evaluation done by specific questionnaires, a scoring will be determined. |
at 3 months
|
|
a qualitative sociological analysis among spouses of patients
Time Frame: at 6 months
|
Conduct a qualitative sociological analysis among spouses of patients treated with Herceptin ®. An interview with a sociologist will be done and characteristic sociologic of patients will be described. |
at 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Corinne DELCAMBRE, MD, Centre François Baclesse
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HER-ception
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